Lung CancerNCT06141005
Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer
A study testing Ultrathin bronchoscopy with intratumoral washing in people with Lung Cancer, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ultrathin bronchoscopy with intratumoral washing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years
- Obtained written informed consent
- No contraindication to bronchoscopy
- Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
- Subjects planning to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing
Who cannot join
- Subjects who withdraw informed consent
- Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement
- Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion
- Subjects diagnosed with a benign lesion from the lung tissue lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Non-small Cell Lung Cancer
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.
Read the detailed description
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.
- Conditions
- Lung Cancer
- Being tested
- Ultrathin bronchoscopy with intratumoral washing
- Keywords
- Bronchoscopy, Liquid biopsy, Lung Cancer, Next Generation Sequencing
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrathin bronchoscopy with intratumoral washingDiagnostic test
Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrathin bronchoscopy with intratumoral washing | Experimental | Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing. Receives: Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set
Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
The concordance rate for the detection of druggable genetic mutations among bronchial washing fluid, plasma, and tissue samples using Next Generation Sequencing in the analysis intent group
The concordance rate of druggable genetic alterations detected in bronchial washing fluid by Next Generation Sequencing is compared with that in plasma and tissue in the analysis intent group. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The analysis intent group consisted of the subset of subjects for whom Next Generation Sequencing testing was successfully performed with tissue samples.
Measured: through study completion, an average of 1 year
Comparisons of the detection rates of representative co-occurring genetic alterations in bronchial washing, plasma, and tissue samples across the full patient set
Detection rate of co-occuring genetic alteration is defined as the number of true positive co-occurring genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Co-occurring genetic alterations were defined as the presence of following GAs: 1) ATM mutation, 2) CDKN2A mutation, 3) CTNNB1 mutation, 4) FGFR1 mutation, 5) KEAP1 mutation, 6) MDM2 amplification, 7) MET amplification, 8) MYC amplification, 9) PIK3CA mutation 10) RB1 mutation, 11) STK11 mutation and 12) TP53 mutation. The full patient set included all enrolled subjects.
Measured: through study completion, an average of 1 year
The incidence of adverse events associated with the bronchial washing procedure
The frequency and severity of adverse events resulting from bronchial washing procedures
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start30 Nov 2023
- Primary completion29 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Seop Eom, MD, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141005
- Sponsor's protocol ID
- 2310-011-132
- Status last verified
- Aug 2025
- First submitted
- 3 Nov 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06141005
- Acronym / sponsor ID
- 2310-011-132
- Conditions
- Lung Cancer
- Keywords
- Bronchoscopy, Liquid biopsy, Lung Cancer, Next Generation Sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.
Detailed description
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrathin bronchoscopy with intratumoral washing | Experimental | Diagnostic Test: Ultrathin bronchoscopy with intratumoral washingEach subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 20 years
- Obtained written informed consent
- No contraindication to bronchoscopy
- Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
- Subjects planning to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing
Key exclusion criteria (4 listed)
- Subjects who withdraw informed consent
- Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement
- Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion
- Subjects diagnosed with a benign lesion from the lung tissue lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrathin bronchoscopy with intratumoral washingEach subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. | Diagnostic test | Ultrathin bronchoscopy with intratumoral washing |
Primary outcome
Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set
Time frame: through study completion, an average of 1 year
Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.
3 secondary outcomes
The concordance rate for the detection of druggable genetic mutations among bronchial washing fluid, plasma, and tissue samples using Next Generation Sequencing in the analysis intent group
Time frame: through study completion, an average of 1 year
Comparisons of the detection rates of representative co-occurring genetic alterations in bronchial washing, plasma, and tissue samples across the full patient set
Time frame: through study completion, an average of 1 year
The incidence of adverse events associated with the bronchial washing procedure
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Seop Eom, MD, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrathin bronchoscopy with intratumoral washing in people with Lung Cancer, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.